A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials
22 april 2019 uppdaterad av: Case Comprehensive Cancer Center
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family.
The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers.
The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment.
The team can make referrals to other specialists.
Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.
Secondary Objective(s):
1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.
Exploratory:
- To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
- To compare caregiver burden and quality of life between the study arms.
Studietyp
Interventionell
Inskrivning (Faktisk)
132
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ohio
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Cleveland, Ohio, Förenta staterna, 44106
- Case Comprehensive Cancer Center
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Patient Inclusion Criteria:
- Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
- Patients are eligible to enroll on this study with or without the enrollment of their caregiver.
Patient Exclusion Criteria:
- Patients diagnosed with a hematologic malignancy.
Caregiver Inclusion Criteria:
- Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
- Caregivers must be willing to complete surveys at baseline and on monthly basis.
Caregiver Exclusion Criteria:
- Caregivers who are solely professional, paid caregivers
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard Supportive Care
|
Supportive care for the patient and caregiver will be provided by the treating oncologist.
|
|
Experimentell: Structured Supportive Care
|
Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Average total MSAS score
Tidsram: Up to 6 months
|
Assessment of patient burden
|
Up to 6 months
|
|
Average total FACT-G score
Tidsram: Up to 6 months
|
Measure patient quality of life
|
Up to 6 months
|
|
Reason for study discontinuation (Patient reported outcome)
Tidsram: Up to 6 months
|
Measure of central tendency for why patients discontinued the phase I study.
Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
|
Up to 6 months
|
|
Duration on Study
Tidsram: Up to 6 months
|
Measure of central tendency of the duration patients were on the phase I study.
Duration on study will serve as the primary objective for sample size determination
|
Up to 6 months
|
|
Adverse events
Tidsram: Up to 6 months
|
Measure of central tendency of adverse events.
AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities).
The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed.
An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event.
These scores will be compared between study arms
|
Up to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean number of hours of palliative care services
Tidsram: Up to 6 months
|
Mean number of hours utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
|
Up to 6 months
|
|
Type of palliative care services
Tidsram: Up to 6 months
|
Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care.
This analysis will be descriptive, reporting measures of central tendency
|
Up to 6 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Frequency of adverse events of patients receiving structured and usual supportive care
Tidsram: Up to 6 months
|
Up to 6 months
|
|
|
Average days on study
Tidsram: Up to 6 months
|
Up to 6 months
|
|
|
Change in FACT-G score
Tidsram: From baseline to last contact, up to 6 months
|
Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
|
Change in MSAS score
Tidsram: From baseline to last contact, up to 6 months
|
Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
|
Change in CRA score
Tidsram: From baseline to last contact, up to 6 months
|
Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
|
Change in QOLLTI-F score
Tidsram: From baseline to last contact, up to 6 months
|
Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care
|
From baseline to last contact, up to 6 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Michelle Treasure, MD, Metrohealth Medical Center and Case Comprehensive Cancer Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
25 oktober 2015
Primärt slutförande (Faktisk)
10 januari 2019
Avslutad studie (Faktisk)
10 januari 2019
Studieregistreringsdatum
Först inskickad
4 september 2015
Först inskickad som uppfyllde QC-kriterierna
4 september 2015
Första postat (Uppskatta)
7 september 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CASE5Y15
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